510(k) K083489 ยท MCW Catheter, Peripheral, Atherectomy
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
| Applicant | Pathway Medical Technologies, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Jan 23, 2009 |
| Received | Nov 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083489
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.